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NCT04634409 · ClinicalTrials.gov registry record · Phase 2
A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
A Phase 2 study of COVID-19, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,755
- Enrollment target
- 20
- Study locations
NCT04634409: Completed Phase 2 study of COVID-19, sponsored by Eli Lilly and Company.
NCT04634409 is a Phase 2 study of COVID-19 that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,755 participants, below the 38,459-participant average among 298 other COVID-19 trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634409, a Phase 2 study of COVID-19, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,755 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.
Primary Outcome
Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bamlanivimab
- DRUG Etesevimab
- DRUG VIR-7831
- DRUG Bebtelovimab
Study Locations (20)
California
- Smart Cures Clin Research - Anaheim
- Hope Clinical Research - Canoga Park
- VCT-Covina - Covina
- Neighborhood Healthcare - Escondido
- Chemidox Clinical Trials - Lancaster
- Ark Clinical Research - Long Beach
- Long Beach Clinical Trials LLC - Long Beach
- Cedars Sinai Medical Center - Los Angeles
- Central Valley Research, LLC - Modesto
- Inland Empire Liver Foundation - Rialto
- Sutter Institute For Medical Research - Sacramento
- Wolverine Clinical Trials, LLC - Santa Ana
Arizona
- The Institute for Liver Health - Mesa
- Perseverance Research Center - Scottsdale
- CRI of Arizona, LLC - Sun City West
- Fiel Family and Sports Medicine PC - Tempe
- The Institute for Liver Health - Tucson
Arkansas
- KLR Business Group, Inc. dba Arkansas Clinical Research - Little Rock
- Applied Rsch Ctr - Arkansas Inc. - Little Rock
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,755 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2021-10-18 |
| Phase | Phase 2 |
What the finished NCT04634409 record still lists
NCT04634409 is an interventional study that assigns participants to a tested intervention. Its 1,755 participants enrollment target places it among the larger protocols in the corpus, below the 38,459-participant average among 298 other COVID-19 trials with a reported enrollment target (95% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04634409 names 20 study sites across 4 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04634409 about?
NCT04634409 is a clinical study titled "A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness". The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much viru...
What is the current status of trial NCT04634409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,755 participants. The study started on 2020-10-29. Estimated completion is 2021-10-18.
What conditions does trial NCT04634409 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04634409?
The interventions under investigation include: Placebo (DRUG), Bamlanivimab (DRUG), Etesevimab (DRUG), VIR-7831 (DRUG), Bebtelovimab (DRUG).
Who is sponsoring clinical trial NCT04634409?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04634409 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04634409's enrollment target sits among peer trials
1,755 51st of 298 higher than 248 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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